Physiotherapy or surgery for repeat kneecap dislocation: a randomised controlled trial
| ISRCTN | ISRCTN17972668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17972668 |
| IRAS number | 312908 |
| Secondary identifying numbers | CPMS 55618, IRAS 321908 |
- Submission date
- 12/04/2023
- Registration date
- 09/06/2023
- Last edited
- 25/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
A kneecap (patellar) dislocation, where the kneecap comes out to the side of the knee, is very painful. It is a common problem for people in their teens and early twenties. After the first dislocation, the weakened muscles and structures around the knee can allow this to happen again. People often feel that the kneecap is going to dislocate and change their activities to prevent it coming out. This combination of repeated dislocations, and the feeling that it is going to happen, is unpleasant, painful, and stops people getting on with their normal lives (education, work and social activity). We do not know the best way to treat this problem. Some specialists believe that without surgery, dislocations and restriction will continue. Others believe that physiotherapy works well and avoids the risks and cost of surgery. We will offer and compare two different treatments to people who have repeated kneecap dislocation; personalised knee therapy, which includes physiotherapy and individual care and advice to prevent dislocation, or surgery which tightens structures around the knee to prevent dislocation.
Who can participate?
Individuals will be eligible for the trial if they are aged 16 years and over and have experienced at least two (self-reported) lateral patellar dislocations affecting the same knee.
What does the study involve?
Participants will be provided information about the trial and given the opportunity to ask questions before providing informed consent. Participants will then be randomly assigned to receive either personalised knee therapy, which includes physiotherapy and individual care and advice to prevent dislocation, or surgery, which tightens structures around the knee to prevent dislocation. We will collect health and medical information from these participants before they are randomly assigned to each treatment options, as well as 6, 12, 18 and 24 months after
What are the possible benefits and risks of participating?
There are no additional risks over and above what the surgeon/treating clinicians would normally inform people about. The requirement to undergo surgical consent or consent for treatment remains in place following normal site specific NHS policies and procedures. The risks with surgery include persistent knee pain, infection and blood clots, but these are the same risks for patients that do not take part in the study who undergo surgery. The risks of PKT are minimal but include post-intervention pain, muscle soreness, or tiredness. The risk associated with PKT are also the same for patients that do not take part in the study but have routine physiotherapy.
Where is the study run from?
The study is led by the University of Warwick and participants will be recruited at various NHS hospitals across the UK.
When is the study starting and how long is it expected to run for?
January 2023 to August 2027
Who is funding the study?
The study is funded by the NIHR Health Technology Assessment (HTA) programme (UK)
Who is the main contact?
Mrs Manjit Aujla: REPPORT Trial Manager; REPPORT@warwick.ac.uk
Contact information
Scientific
Warwick Clinical Trials Unit
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 24 765 74996 |
|---|---|
| REPPORT@warwick.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Physical, Surgery, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43475 REPPORT PIS V3.0_04Apr2023.pdf |
| Scientific title | REcurrent Patellar dislocation: Personalised therapy or OpeRative Treatment? (REPPORT) |
| Study acronym | REPPORT |
| Study hypothesis | Clinical outcomes will be different between people with recurrent patellar dislocation who are offered physiotherapy or surgery as their first line treatment. |
| Ethics approval(s) | Approved 30/03/2023, East Midlands: Nottingham 2 REC (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 2071048016; nottingham2.rec@hra.nhs.uk), ref: 23/EM/0075 |
| Condition | Recurrent patellar dislocation |
| Intervention | Randomisation: After consent has been obtained and baseline data have been collected, participants will be randomly allocated to one of the two treatment groups via a central computer-based randomisation system provided by Warwick Clinical Trials Unit’s programming team. Randomisation will be in a 1:1 ratio using a minimisation procedure with a random factor of at least 70%, stratified by age group (<22/≥22), site of recruitment, and presence of patella alta in the study knee. Trial interventions: A full summary of the PKT and surgical interventions will be available in the REPPORT manuals which will be prepared following surgical and non-surgical consensus meetings. These manuals will be made available on the REPPORT trial webpage for ease of access for participants randomised to respective allocation groups. Personalised Knee Therapy (PKT) The PKT programme is an optimised package of tailored non-operative care for patellar instability and will be based on the PKT programme developed for the PIPS feasibility trial. It will be developed further using data from the PIPS participant interviews, an evaluation of current relevant literature, our 2020 physiotherapy survey findings, and a consensus meeting of expert patients, PPI representatives, physiotherapists, health psychologists, and other stakeholders and practitioners with a specialist interest in knee rehabilitation. Surgery A REPPORT surgical manual will be produced based on published British Orthopaedic Association Standards for Trauma and Orthopaedics (BOAST) guidelines and the outcomes of a surgical consensus meeting comprising surgeons, patients, physiotherapists and other key stakeholders. The most widely recommended surgical procedure for patellar dislocation is medial patello-femoral ligament (MPFL) reconstruction. Participants with patella alta may also undergo a simultaneous tibial tubercle osteotomy. All care, including the choice of anaesthetic, the surgical procedure, and post-operative analgesia, will be in accordance with usual procedures and care at participating sites. Fidelity and process measures will be assessed and recorded on a case report form (CRF). These will include details of surgery (surgical procedure, surgical findings, theatre time, tourniquet time, any other procedures) and the anaesthetic used. Rehabilitation following surgery will based on the minimum standard of care consistent with normal NHS practice, as used in the PIPS feasibility trial |
| Intervention type | Mixed |
| Primary outcome measure | Knee Osteoarthritis Outcome Score (KOOS4) score at 18 months after randomisation |
| Secondary outcome measures | 1. KOOS4 at baseline, pre-intervention, six, 12, and 24-months. 2. The five individual KOOS domains (symptoms, pain, activities of daily living, sports, quality of life) at baseline, preintervention, six, 12, 18, and 24-months post randomisation. 3. Norwich Patellar Instability (NPI) score at baseline, pre-intervention, six, 12, 18, and 24-months post-randomisation. 4. Health utility (EQ-5D-5L) at baseline, pre-intervention, six, 12, 18, and 24-months post-randomisation. 5. Work or education status (time off, change to status) at baseline, six, 12, 18, and 24-months post randomisation. 6. Satisfaction with social roles (PROMIS Satisfaction with Social Roles and Activities 4a Short Form) at baseline, six, 12, 18, and 24-months post randomisation. 7. Satisfaction with treatment at six, 12, 18, and 24-months post-randomisation using a 5-point Likert scale. 8. Patient global impression of change (PGIC) scale (single item) at six, 12, 18, and 24-months post-randomisation. 9. Patellar dislocations at baseline, six, 12, 18, and 24-months post-randomisation. 10. Adverse events including surgical complications at six, 12, 18, and 24-months post-randomisation. 11. Further knee surgery (either arm) at six, 12, 18, and 24-months post-randomisation. 12. Resources used by interventions and assessed at six, 12, 18, and 24-months post-randomisation. |
| Overall study start date | 01/01/2023 |
| Overall study end date | 31/08/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 276; UK Sample Size: 276 |
| Participant inclusion criteria | 1. Experienced at least two (self-reported) lateral patellar dislocations affecting the same knee 2. Age 16 years or over |
| Participant exclusion criteria | Current participant exclusion criteria as of 18/06/2024: 1. Open growth plates on standard care imaging (typically but not restricted to MRI). Surgery in the skeletally immature requires different surgical techniques and is beyond the scope of this trial. 2. Presence of another knee condition which may cause instability (e.g., cruciate ligament instability, unstable meniscal tear) 3. Previous patellofemoral surgery, except simple arthroscopy with/without lateral release 4. Severe trochlea dysplasia which in the opinion of the treating clinician requires trochleoplasty.* 5. Malalignment of femur or tibia requiring corrective osteotomy (not including tibial tubercle osteotomy).* 6. Osteochondral/chondral injury requiring surgery, except removal of loose body. 7. Medial patellar dislocation or dislocations when the knee flexes (i.e., the patella is located in extension and dislocates every time the knee flexes). 8. Previous randomisation into the trial (i.e., the other knee). 9. Unable to have either physiotherapy or surgery. 10. Unable to adhere to trial protocols or completion of questionnaires (the need to offer translations will be kept under review by the trial team). * These are uncommon, <10% of the population, and challenging to treat. Previous participant exclusion criteria: 1. Open growth plates on standard care imaging (typically but not restricted to MRI). Surgery in the skeletally immature requires different surgical techniques and is beyond the scope of this trial 2. Presence of another knee condition which may cause instability (e.g., cruciate ligament instability, unstable meniscal tear) 3. Previous patellofemoral surgery, except simple arthroscopy with/without lateral release 4. Severe trochlea dysplasia requiring trochleoplasty* 5. Malalignment of femur or tibia requiring corrective osteotomy (not including tibial tubercle osteotomy)* 6. Osteochondral/chondral injury requiring surgery 7. Medial patellar dislocation 8. Previous randomisation into the trial (i.e., the other knee) 9. Unable to adhere to trial protocols or completion of questionnaires (the need to offer translations will be kept under review by the trial team) *These are uncommon, <10% of the population, and are challenging to treat |
| Recruitment start date | 01/07/2023 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Coventry
CV2 2DX
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Stockport
SK2 7JE
United Kingdom
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Pontypridd
CF37 1LB
United Kingdom
Caerleon
Newport
NP18 3XQ
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Airdrie
ML6 0JS
United Kingdom
Taunton
TA1 5DA
United Kingdom
Court Road
Chelmsford
CM1 7ET
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Margate
CT9 4AN
United Kingdom
Dundee
DD1 9SY
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Altnagelvin Area Hospital Site
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Port Talbot
SA12 7BR
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Charter Way
Turner Road
Colchester
CO4 5JL
United Kingdom
Newport
NP20 2UB
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Leeds
LS9 7TF
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Sponsor information
University/education
University House
Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 2476575733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/08/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Warwick Clinical Trials Unit (WCTU) Data Sharing Committee (WCTUDataAccess@warwick.ac.uk) once the study is complete and published. De-identified data that underlie the results reported in the study will be available for non-commercial use, up to one year after publication of the final trial data, or from metadata stored in a university repository up to ten years without investigator support. To access trial data, third parties must complete a data-sharing agreement with the sponsors, have an ethically approved protocol in place for use of the data, and agree the approved protocol with the WCTU data sharing committee. Data may be used for commercial purposes, according to the conditions above, but will need specific agreements in place prior to access being agreed, this may include a license fee. Analyses may include individual patient data meta-analyses or other purposes as agreed with the WCTU data sharing committee. Available data will include (but is not exclusive to) de-identified individual participant data that underlies the results reported in trial publications, the study protocol, statistical analysis plan, master copy of the informed consent sheets and analytic codes used. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 04/04/2023 | 09/06/2023 | No | Yes |
| Participant information sheet | version 5.0 | 29/11/2023 | 18/06/2024 | No | Yes |
| Protocol file | version 4.0 | 29/11/2023 | 18/06/2024 | No | No |
| Protocol article | 21/08/2024 | 23/08/2024 | Yes | No | |
| Protocol file | version 6.0 | 25/10/2024 | 25/03/2025 | No | No |
Additional files
Editorial Notes
25/03/2025: The following changes were made:
1. The study participating centres, Colchester General Hospital, Royal Gwent Hospital, Queen Margaret Hospital, Southampton General Hospital, New Cross Hospital Royal Wolverhampton, Queen Alexandra Hospital, St James's University Hospital, Milton Keynes University Hospital NHS Foundation Trust, and Torbay Hospital, were added.
2. Protocol file (not peer reviewed) version 6.0 was uploaded.
23/08/2024: Publication reference added.
18/06/2024: The following changes were made:
1. Protocol (not peer reviewed) and patient information sheet added.
2. The study contact was updated.
3. The participant exclusion criteria were changed.
4. The following study participating centres Cumberland Infirmary, University Hospital Monklands, Musgrove Park Hospital, Broomfield University Hospital, Royal Bolton Hospital, Southmead Hospital, William Harvey Hospital, Queen Elizabeth The Queen Mother Hospital, Ninewells Hospital, Lewisham and Greenwich NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, Western Health and Social Care Trust, University Hospitals of Leicester NHS Trust, Swansea Bay University Health Board, Ipswich Hospital were added.
5. Website added.
13/04/2023: Trial's existence confirmed by the NIHR.
